AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST
FDA premarket approval P940040 · decided 1996-11-26
Approval details
- PMA number
- P940040
- Trade name
- AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST
- Generic name
- System, nucleic acid amplification, mycobacterium tuberculosis complex
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 1994-12-22
- Decision date
- 1996-11-26
- Days to decision
- 705 days
- Decision code
- APWD
- Product code
- MWA
- Advisory committee
- Microbiology
- Expedited review
- Yes
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE AMPLICOR(R) MYCOBACTERIUM TUBERCULOSIS(MTB) TEST. THE DEVICE IS A TARGET AMPLIFIED IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF M.TUBERCULOSIS COMPLEX DNA IN CONCENTRATED SEDIMENTS PREPARED FROM SPUTUM (INDUCED OR EXPECTORATED), BRONCHIAL SPECIMENS INCLUDING BRONCHOALVEOLAR LAVAGES OR ASPIRATES, OR TRACHEAL ASPIRATES.
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510(k) clearances by this applicant
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|---|---|---|
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